TEMPO 451415H0Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705032007863), received between Jun 24, 2019 and Nov 5, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Degraded” (4 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478275 ↗
• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478206 ↗
• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478080 ↗
• MalfunctionNov 5, 2025Degraded; Degraded

  AS REPORTED, A 5 F TEMPO AQUA 0.038" 65CM CATHETER BEGAN CRUMBLING DURING A PROCEDURE. THE CATHETER WAS NOT USED AT THE TIME OF NOTICING THE FLAKING. A DIFFERENT UNKNOWN CATHETER WAS USED. THE PATIENT LATER EXPIRED THAT DAY. IT IS STATED THAT THE TECH WIPED HIS HANDS AND NOTICED BLUE FLAKES ON HIS GLOVES AND CHECKED THE CATHETER AND NOTICED IT WAS "CRUMBLING", AND THAT NONE OF THE CATHETER FLAKED OFF IN THE PATIENT'S BODY, JUST ON THE STERILE FIELD. THE CATHETER DID NOT FLAKE OFF INSIDE THE PATIENT¿S BODY; THE FLAKING OCCURRED ON THE STERILE FIELD AND WAS NOTICED DURING THE PROCEDURE BEFORE BEING PASSED TO THE PHYSICIAN. THE DEVICE WAS PREPPED AND FLUSHED, WITH NO DIFFICULTIES ENCOUNTERED DURING PREPARATION. THERE WAS NO NEED TO REPLACE THE STERILE FIELD, GLOVES, OR GOWN AFTER NOTICING THE FLAKING. THE PROCEDURE WAS A PERIPHERAL INTERVENTION CONDUCTED ON AN OUTPATIENT BASIS FOR PERIPHERAL ARTERY DISEASE (PAD). THE PATIENT DIED DUE TO AN ACCESS SITE BLEED AND EXHIBITED HYPOTENSION PRIOR TO EXPIRING. THE DEVICE WAS NOT EXPOSED TO HEAT OR STORED IN A DARK LOCATION, AND THE FACILITY DOES NOT USE UV LIGHTING OR OZONE FOR STERILIZATION OR MICROBIAL REDUCTION. THE TARGET SITE WAS THE COMM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23475589 ↗
• InjuryJun 24, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, A 4F TEMPO BER II 100CM CATHETER DISTAL TIP BECAME DETACHED CAUSING EMBOLIZATION OF THE POSTERIOR TIBIAL ARTERY. ADDITIONALLY, THE INCIDENT HAS LED TO A PROCEDURE DELAY IN ORDER TO RETRIEVE THE CATHETER¿S TIP. THE TARGET LESION WAS THE SUPERFICIAL FEMORAL ARTERY (SFA). THERE WAS SEVERE CALCIFICATION. THERE WAS NOT ANY VESSEL TORTUOSITY. THERE WAS NOT ANY VESSEL ANGULATION. THE DEVICE WAS BEING USED TO TREAT CHRONIC TOTAL OCCLUSION (CTO). THE DEVICE WAS NOT RESTERILIZED. THERE WERE NOT ANY ANOMALIES NOTED WHEN REMOVED FROM THE PACKAGE. THERE WERE NOT ANY ANOMALIES NOTED DURING PREP. THE DEVICE WAS NO INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE. RESISTANCE WAS MET WHILE ADVANCING THE DEVICE. EXCESSIVE TORQUING WAS REQUIRED. RESISTANCE WAS MET ONLY WHEN CROSSING THE OCCLUSION. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. RESISTANCE WAS NOT MET WHILE WITHDRAWING THE DEVICE. THE DISTAL END SEPARATED AT THE TIP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8728303 ↗